MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047

K091961 · Concentric Medical, Inc. · DQO · Jul 30, 2009 · Cardiovascular

Device Facts

• Record ID: K091961
• Device Name: MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
• Applicant: Concentric Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Device Story

Modified Concentric Microcatheter is a single-lumen, braided, variable-stiffness catheter; features distal radiopaque marker and proximal luer hub; includes hydrophilic coating to reduce friction. Used by physicians in clinical settings for selective delivery of fluids, devices, or agents into peripheral, coronary, or neuro vasculature. Device facilitates diagnostic and therapeutic procedures by providing access to target vessels.

Clinical Evidence

Bench testing only; verification and validation demonstrated the device performs as designed and is suitable for its intended use.

Technological Characteristics

Single-lumen, braided, variable-stiffness shaft; radiopaque distal marker; proximal luer hub; hydrophilic coating. Materials are biocompatible and previously cleared.

Indications for Use

Indicated for selective placement of fluids, devices, or agents into peripheral, coronary, and neuro vasculature during diagnostic or therapeutic procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Concentric Microcatheter (K003086)

Submission Summary (Full Text)

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K091961

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### IJUL 30 2009

#### General Information

| Trade Name | Concentric Microcatheter |
|----------------|--------------------------------------------------------------|
| Common Name | Diagnostic Intravascular Catheter |
| Classification | Diagnostic Intravascular Catheter, 21CFR 870.1200 - Class II |
| Submitter | Concentric® Medical, Inc. |
| | 301 E. Evelyn Avenue |
| | Mountain View, CA 94041 |
| | Tel [phone] |
| | Fax [phone] |
| Contact | Kirsten Valley |
| | Senior Vice President, Technology & Regulatory Affairs |

#### Intended Use

The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

#### Predicate Device

Concentric Microcatheter, K003086

#### Device Description

The Modified Concentric Microcatheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use.

#### Materials

All materials used in the manufacture of the Modified Concentric Microcatheter are suitable for the intended use of the device and have been used in numerous previously cleared products.

#### Testing Summary

The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.

#### Summary of Substantial Equivalence

The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Moditied Concentric Microcatheter and the predicate device do not raise any new issues of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 30 2009

Concentric Medical % Ms. Kirsten Valley 301 East Evelyn Avenue Mountain View. California 94041

Re: K091961

Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: June 29, 2009 Received: July 1, 2009

Dear Ms. Valley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing

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Page 2-Ms. Kirsten Valley

practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance..

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Singerely yours,

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Concentric Medical, Inc. Special 510(k): Device Modification Concentric Microcatheter

### INDICATIONS FOR USE

510(k) Number (if known):

This application - K091961

Modified Concentric Microcatheter

Device Name:

Indications for Use:

The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Prescription Use X (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off) Division of Cardiovascular Devices 510(k) Number_Kog

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